{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-12",
    "results": {
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  "results": [
    {
      "pma_number": "P960013",
      "supplement_number": "",
      "applicant": "ABBOTT MEDICAL",
      "street_1": "15900 Valley View Ct.",
      "street_2": "",
      "city": "Sylmar",
      "state": "CA",
      "zip": "91335",
      "zip_ext": "",
      "generic_name": "Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes",
      "trade_name": "TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS",
      "product_code": "NVN",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "1996-05-10",
      "decision_date": "1997-06-20",
      "docket_number": "98M-0450",
      "fed_reg_notice_date": "1998-07-16",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE TENDRIL(R) DX MODELS 388T/K ENDOCARDIAL, STEROID ELUTING, SCREW-IN PACING LEADS AND VENTRITEX ASSURE(TM) AFS MODELS 7010T/K ENDOCARDIAL, STERIOID ELUTING SCREW-IN PACING LEADS.  THESE DEVICES ARE INDICATED FOR USE IN COMBINATION IWTH A COMPATIBLE PULSE GENERATOR TO PROVIDE PERMANENT PACING AND SENSING IN EITHER THE ATRIUM OR VENTRICLE.",
      "openfda": {
        "registration_number": [
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        "device_name": "Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
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}